Catheter assembly with resealable opening

ABSTRACT

A medical device assembly is disclosed, including a medical device, preferably having a hydrophilic surface coating, and a package accommodating said medical device. The package if formed of two sheets of foil material, a first foil of which has been deep drawn into a trough shape, the package further including a resealable opening arranged within the bounds of the second foil. The medical device may e.g. be a urinary catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 14/485,997, filed Sep. 15, 2014, which is a continuation ofU.S. patent application Ser. No. 13/714,940, filed Dec. 14, 2012, nowabandoned, which further claims the benefit of and priority to EuropeanApplication No. 11195736.1, filed on Dec. 27, 2011, and U.S. ProvisionalPatent Application No. 61/580,464, filed on Dec. 27, 2011, which areherein incorporated by reference for all purposes.

FIELD OF THE INVENTION

The present invention relates to a medical device assembly comprising amedical device and a resealable package accommodating the medicaldevice. Specifically, the invention pertains to a medical device havinga hydrophilic surface coating, wherein the assembly also includes awetting fluid for activation of the hydrophilic surface coating. Theinvention is particularly related to catheters, and specifically tourinary catheters.

BACKGROUND OF THE INVENTION

The present invention relates to a medical device assembly, and inparticular for urinary hydrophilic catheters. Catheters are commonlyused for draining bodily fluids, e.g. from the bladder. Urinarycatheters are e.g. used by a large group of persons for intermittentcatheterization, which is a daily-life procedure, taking place severaltimes a day. Typically catheters for intermittent catheterization areused by patients suffering from urinary incontinence or by disabledindividuals like para- or tetraplegics. Using an intermittent catheter,the bladder may be drained through a natural or artificial urinarycanal. Many catheters for intermittent catheterization are provided witha hydrophilic coating or the like, providing a smooth and slipperysurface when wetted, for safe and comfortable insertion in the urinarycanal.

Many hydrophilic catheter assemblies include a supply of wetting fluid,either in direct contact with the catheter or in a separate compartment,for clean and convenient activation of the hydrophilic surface beforeuse.

However, there is still a need for improved packages for such catheterassemblies. The package should preferably be relatively simple andcost-efficient to produce. Further, the package should be easy to open,even for users with reduced dexterity. Still further, the package shouldenable adequate wetting of the catheter, and handling of the package ina clean manner. The package should also preferably be rather small, sothat it can easily be carried around by the user in his/her daily life.It would also be highly advantageous if the package is resealable, sothat the catheter package could be re-closed after use, if it cannot beimmediately disposed of. In particular, it would be advantageous if thepackage would be resealable to enclose also a wet product and/or awetting fluid without any risk for spillage.

Patent application US 2011/056852 by the same applicant discloses aurinary catheter assembly having a resealable opening. However, eventhough this catheter assembly is highly useable for short catheters, forfemale users, re-insertion of longer catheters, typically for maleusers, may be cumbersome and with the risk of spillage and the like.Male catheters may be 40 cm long, or even longer, and insertion of thetip portion through the resealable opening without touching theinsertable part of the catheter is rather difficult, especially forusers with reduced dexterity. Further, closing of the resealable openingafter re-insertion of the catheter in a sufficiently sealed manner mayalso be difficult with this known catheter assembly, and again,especially for users with reduced dexterity. There is therefore a needfor a catheter assembly with resealable opening enabling easierre-insertion of the catheter.

Many other types of medical devices face similar problems.

In conclusion there is still a need for an improved medical deviceassembly of the above discussed general type.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a medicaldevice assembly which at least alleviates the above-discussed problems.

This object is obtained by means of a medical device assembly and amethod in accordance with the appended claims.

According to a first aspect of the invention, there is provided amedical device assembly comprising a medical device, and preferably aurinary catheter, and also preferably having a hydrophilic surfacecoating, and a package accommodating said medical device, wherein thepackage is formed of two sheets of foil material, a first foil of whichhas been deep drawn into a trough shape, the package further comprisinga resealable opening arranged within the bounds of the second foil.

In the context of the present application, “resealing” relates toclosure of a previously opened opening, wherein the closure formsclosure that at least to a large extent prevents liquid from leaking outfrom the closure.

In the context of the present application, “deep drawn” defines anyprocess forming a permanent deformation of a plastic material, such asvacuum forming and other types of thermoforming by means of heating, andthe like. In a preferred embodiment, vacuum forming is used. In vacuumforming, the sheet is heated to a forming temperature, stretched onto orinto a single-surface mold, and held against the mold by applying vacuumbetween the mold surface and the sheet. The mold may e.g. be a cast ormachined aluminum mold, or a composite mold.

In the context of the present application, “trough” defines a shapehaving a rim, thin or wide, encircling a lowered middle section.

The rim is preferably provided with an essentially planar edge portion,encircling the lowered middle section. The depth of the lowered middlesection is preferably sufficient to entirely accommodate the height ofthe medical device and/or the height of a wetting fluid container.Preferably, the depth is in the range 0.2-3 cm, and preferably in therange 0.5-2 cm, and most preferably in the range 0.7-1.5 cm. It isfurther possible to have different depths in different parts of thepackage. For example, a part housing anon-insertable catheter end, andoptionally a wetting fluid container, may have a greater depth than apart housing an insertable part of a catheter.

The second foil is preferably not deep-drawn. Instead, this foil ispreferably essentially planar, or only slightly curved.

This package is very well suited for use for catheters, and inparticular hydrophilic catheters, i.e. catheters being provided with ahydrophilic surface coating or catheters being made of a hydrophilicmaterial. The package enables easy, clean and efficient wetting andhandling of the hydrophilic catheter, and also provides sterileconditions for the entire wetting process. At the same time the packageis relatively simple and cost-efficient to produce. In particular, thecatheter assembly is well-suited for the type of assemblies including ahydrophilic catheter and a wetting fluid being accommodated by thepackage. The wetting fluid may e.g. be arranged directly in contact withthe hydrophilic surface of the catheter, or in a separate compartment ofthe package or in a separate container being housed by the package.

Since the resealable opening is arranged in a non-deep drawn, andpreferably essentially planar sheet, opening and re-closing of theresealable opening is greatly facilitated. It has been found by thepresent inventor that re-arranging a resealable opening into a sealedand sufficiently closed condition is much simpler on a planar or onlyslightly curved surface than on surfaces curved in one or severaldirections. This is particularly advantageous for users having reduceddexterity.

Further, during manufacturing, formation of the resealable opening isalso facilitated, enabling a more cost-efficient production.

Still further, since the first sheet underlying the second sheet withthe resealable opening is deep drawn into a trough shape, a spacingbetween the first and second sheets are formed and continuouslymaintained. This spacing essentially corresponds to the depth of thelowered middle section of the deep drawn trough. Hereby, it is avoidedthat the catheter deforms the second sheet to any significant degree. Itis further ensured that there is a spacing between the sheets also afterwithdrawal of the catheter from the package. This greatly facilitatesre-insertion of the medical device, since re-insertion of the medicaldevice hereby does not necessitate separation of the sheets. Instead,the medical device may simply be guided through the resealable openinginto the already available compartment formed between the sheets. Thisis particularly advantageous for use with relatively long medicaldevices, such as long catheters, when manipulation of the tip portion ofthe catheter by holding the rearward connector end is complicated if itinvolves any other actions than simply guiding the tip into a preformedcompartment of sufficient dimensions. Further, this simplifiedre-insertion is highly advantageous for users with reduced dexterity.

Preferably, the medical device is a hydrophilic urinary catheter forintermittent use. However, even though the catheter assembly is atpresent primarily intended for urinary hydrophilic catheters, where thepackage also includes a wetting fluid, the catheter assembly may also beused for other types of catheters. For example, the catheter may beother types of catheters, such as vein catheters and the like. Further,the catheter may be provided with other types of lubricious coatings,such as gel lubricants and the like, or being without any surfacecoating at all. Still further, assemblies without a wetting fluid arealso feasible. Still further, the assembly of the present invention mayalso be used for other types of medical devices than catheters.

The two sheets of foil material are preferably joined along the edges ofthe foils, and preferably connected around the edges by means ofwelding. Preferably, the first and second sheet materials compriselaminated sheets, having a weldable inner layer and a protective outerlayer.

The resealable opening is preferably arranged at, and preferablyoverlying, the part of the package housing the non-insertable, rearwardend of the medical device/catheter. Hereby, the medical device/cathetermay be withdrawn with the connector end first, which enables a clean andconvenient way of handling the catheter without touching the insertablepart directly by hand.

Preferably, the resealable opening is arranged as a peel opening. Mostpreferably, the resealable opening in the second sheet may comprise aperforation line extending along a non-closed loop in one of saidsheets, said perforation line defining a flap opening, and a third sheetconnected by means of an adhesive over said flap opening, wherein saidthird sheet with a margin covers the entire flap opening. The thirdsheet further preferably forms a tab not provided with adhesive, saidtab providing a grip portion for peel opening of the package.

By “perforation” is meant a diminished material thickness, possiblyextending over the entire thickness, providing a complete cut-through.By means of “perforation line” is meant a line with continuous ordiscontinous perforations. Thus, in the context of the presentapplication, “perforation line” is used to indicate a line forming aweakening, such as a total cut-through, a partial cut-through, pointperlorations, or the like, forming a weakening where a rupture willoccur when a force is exerted on the material.

Such a resealable opening is efficient and easy to use, and alsorelatively simple to produce. The tab enables a vecy simple peel-openingof the package. At the same time, the flap opening provides an efficientway of removing the medical device, and also for resealing of thepackage, once the medical device has been used and been replaced in thepackage.

In production, one of the first and second sheets may be provided withthe non-closed loop perforation line, by means of cutting or the like,and the third sheet material can thereafter be adhered on top of it.Alternatively, the third sheet material can be added first and theperforated line (or total cut) could be formed afterwards.

The adhesive is preferably adapted to maintain a sterile closure of thepackage before use, and to be resealable after use.

The non-closed loop defining the flap opening preferably debouchestowards (i.e. faces) the end of the package housing the insertion end ofthe medical device/catheter. Hereby, the tab is arranged close to theend of the package, and the peeling occurs downwards, towards theinsertion end of the medical device/catheter, which is efficient foravoiding spillage of the wetting fluid within the package afteractivation, especially when the medical device assembly is hanged,adhered or otherwise arranged in a vertical direction during withdrawalfrom the package and re-insertion into the package.

The third sheet preferably covers the entire flap opening with a marginexceeding 2 mm, and preferably exceeding 5 mm. Hereby, a sterile sealmay be obtained before opening of the package, and at the same time anadequate resealing capability may be obtained.

The non-closed loop of the perforation line preferably forms a tonguedirected inwardly towards the non-closed opening of the non-closed loop.

Further, the non-closed loop preferably has loop ends directed towardsthe interior of the non-closed loop. Hereby, it is efficiently avoidedthat the third material sheet is peeled off completely.

The third sheet further preferably comprises a weakened area forming aseal integrity mark. Hereby, it is ensured that the seal has not beenbroken before use, ensuring full integrity of the product. Preferably,the seal integrity mark is arranged between the tab and the part of thethird sheet overlying the perforation line.

Preferably a wetting fluid is also included in the assembly. The wettingfluid may be arranged in direct contact with the hydrophilic surface ofthe medical device. However, preferably the wetting fluid is arrangedseparately from said medical device within the package. The separatearrangement of the wetting fluid can be obtained by means of closedcompartment within the package. However, in a preferred embodiment, thewetting fluid is arranged in a wetting fluid container arranged withinsaid package, such as in a pouch, sachet or the like. In case thewetting fluid is arranged separately, the container or compartment isopenable into the part of the package housing the medical device, inorder to enable release of the wetting fluid into contact with thehydrophilic part of the medical device before use. Release of thewetting fluid can be obtained by squeezing, bending or the like, as isper se well known in the art.

The medical device assembly may further comprise a fourth sheet arrangedon the first sheet, on the side of said package being opposed to theresealable opening, said fourth sheet being connected by means of anadhesive to said first sheet, and forming a tab not provided withadhesive, said tab providing a grip portion for exposure of saidadhesive to form a holding arrangement for said package. By means ofthis fourth sheet material, the medical device assembly may e.g. beattached to a sink, a wall or the like, which enables very efficient andeasy handling of the product, even for user with reduced dexterity.

The package is preferably elongate, and preferably narrowly surroundingthe medical device and the optional wetting fluid compartment. Forexample, the package may have an essentially rectangular form in theforward section, and a larger and also essentially rectangular form inthe rearward section. Hereby, a very cost-efficient and compact productis obtained.

According to a second aspect of the invention, there is provided amethod of producing a medical device assembly comprising the steps:

providing a medical device, preferably a hydrophilic catheter, i.e. acatheter having a hydrophilic surface coating or being made by ahydrophilic material; and

accommodating the medical device, and optionally also a wetting fluid,in a package, said package comprising:

a first and a second sheets of foil material connected around the edges,a first of which has been deep drawn into a trough shape, the packagefurther comprising a resealable opening arranged within the bounds ofthe second foil.

These and other aspects of the invention will be apparent from andelucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

For exemplifying purposes, the invention will be described in closerdetail in the following with reference to embodiments thereofillustrated in the attached drawings, wherein:

FIG. 1 illustrates a perspective view of a medical device assembly inaccordance with an embodiment of the present invention; and

FIG. 2 illustrates an exploded view of the medical device assembly inFIG. 1.

DESCRIPTION OF PREFERRED EMBODIMENTS

In the following detailed description preferred embodiments of theinvention will be described. However, it is to be understood thatfeatures of the different embodiments are exchangeable between theembodiments and may be combined in different ways, unless anything elseis specifically indicated. It may also be noted that, for the sake ofclarity, the dimensions of certain components illustrated in thedrawings may differ from the corresponding dimensions in real-lifeimplementations of the invention, e.g. the length of the medical device,etc.

The medical device assembly can be used for many types of medicaldevices. However, it is particularly suited for catheters. Catheters maybe used for many different purposes, and for insertion into varioustypes of body-cavities. However, the following discussion is inparticular concerned with the preferred field of use, hydrophilicurinary catheters, even though the invention is not limited to thisparticular type of catheters, and also not to catheters.

The catheter assembly as illustrated in FIGS. 1-2 comprises a catheter 1having a hydrophilic surface coating, a wetting fluid for activation ofsaid hydrophilic surface coating and a package 3 accommodating thecatheter and the wetting fluid.

The catheter I may be any type of hydrophilic catheter, as is per sewell known in the art. Preferably, the catheter comprises a flaredrearward portion, forming a flared connector 11, and an elongated shaft12, connected to the flared connector 11, and in the opposite end havinga catheter insertion end 13.

An applicator 14, in the form of e.g. a tube, sleeve or cuff, may bereleasably attached to the connector 11, in order to be release from theconnector prior to insertion, and to aid in manipulating the catheterduring insertion without directly contacting the catheter surface.

At least a part of the elongate shaft 12 forms an insertable length tobe inserted through a body opening of the user, such as the urethra incase of a urinary catheter. By insertable length is normally, in thecontext of a hydrophilic catheter, meant that length of the elongateshaft 12 which is coated with a hydrophilic material, for example PVP,and which is insertable into the urethra of the patient. Typically, thiswill be 50-140 mm for a female patient and 200-350 mm for a malepatient. Even though PVP is the preferred hydrophilic material, otherhydrophilic materials may be used, such as hydrophilic polymers selectedfrom polyvinyl compounds, polysaccharides, polyurethanes, polyacrylatesor copolymers of vinyl compounds and acrylates or anhydrides, especiallypolyethyleneoxide, polyvinyl-pyrrolidone, heparin, dextran, xanthan gum,polyvinyl alcohol, hydroxy propyl cellulose, methyl cellulose, copolymerof vinylpyrrolidone and hydroxy ethylmethyl acrylate or copolymer ofpolymethylvinyl ether and maleinic acid anyhydride. The coating may alsocomprise an osmolality-increasing compound, as is e.g. taught in EP 0217 771.

The wetting fluid is preferably arranged separate from the catheter, ina wetting fluid container 2, such as a pouch or a sachet. The wettingfluid container is openable by means of e.g. exerting a pressure to thecontainer, whereby the wetting fluid is released into the package,thereby wetting the hydrophilic surface of the catheter. The wettingfluid is preferably a liquid, and most preferably an aqueous liquid,such as water or saline. Such wetting fluid containers and wettingfluids are per se well known in the art. The flexible material used forwetting fluid pouch is preferably a flexible material which provides amoisture barrier or low water vapor transmission. The flexible materialmay e.g. comprise or consist of one or several of aluminum, aluminumoxide, silicone oxide, metallocene polyvinylidene chloride (PVdC) andpoly(ethylene-vinylalcohol) (EVOH). For example, the flexible materialcan be made as coextruded polyolefines with polyamides,poly(ethylene-terephthalate) (PET), including barrier resins such aspolyvinylidene chloride (PVdC) or poly(ethylene-vinylalochol) (EVOH).However, other materials exhibiting similar properties are alsofeasible.

The wetting fluid may be any fluid that wets a hydrophilic surface ofthe catheter.

Preferably, the wetting fluid container 2 is arranged close to, and mostpreferably overlying, the connector end of the catheter.

The package comprises a first sheet material 4 and a second sheetmaterial 5, connected around the edges to form an inner cavity housingthe catheter and the wetting fluid. The first and second sheet materialsare preferably connected around the edges by means of welding, forming awelded edge joint 6. Preferably, the first and second sheet materialscomprise laminated sheets, having a weldable inner layer and aprotective outer layer.

The sheet materials are preferably of a flexible plastics material. Thematerial may be transparent, but opaque or semi-opaque materials mayalso be used. For example, the sheets can be made of polymer materialssuch as polyethene (PE), polypropylene {PP), polyamide (PA),poly(ethylene terephthalate) (PET), oriented polypropylene (OPP),oriented polyamide (OPA), etc. Also, the receptacle can be made from alammate of such polymer materials and/or aluminum, aluminum oxide orother materials functioning as barrier materials.

The first sheet material 4 is deep drawn into a trough shape, therebyforming an upper rim 41, to be m contact with the second sheet material5, and a lower middle section, formed to accommodate the catheter andthe wetting fluid sachet. The rim is preferably provided with anessentially planar edge 42 surrounding the lowered middle section. Theplanar edge may have any dimensions, such as being very thin or beingrelatively wide. Further, the planar edge may have various dimensionsaround the circumference. The second sheet material 5 is preferablyessentially planar, or only slightly curved.

The second sheet material 5 comprises a resealable opening 7. Theresealable opening preferably comprises a perforation line 71 in thesecond sheet material, extending along a non-closed loop defining a flapopening. The non-closed loop defining the flap opening is preferablyarranged over the connector end of the catheter 1. Further, thenon-closed loop preferably has an opening 72 debouching towards the endof the package housing the insertion end of the catheter. At the end,the non-closed loop preferably forms a tongue 73 directed inwardlytowards the non-closed opening of the non-closed loop. The loop ends, atthe opening 72, are preferably directed towards the interior of thenon-closed loop.

The non-closed loop generally forms a C- or U-shape.

The resealable opening further preferably comprises a third sheetmaterial 74, arranged over the non-closed loop, and connected to thesecond sheet material 5 by means of an adhesive. The third sheetmaterial is preferably arranged to cover the entire flap opening with amargin, preferably exceeding 2 mm, and most preferably exceeding 5 mm.An end of the third sheet material is not adhered to the first sheetmaterial, and forms a tab 75 providing a grip portion for peel openingof the package. The tab is preferably arranged in the end directedtowards the insertable part of the catheter. Further, the tab may beprovided with gripping means to facilitate gripping of the tab. Thegripping means may e.g. be one or several of a surface coating, surfaceroughening, corrugations, embossment, perforations or a larger grippingopening, etc.

The adhesive is adapted to maintain a sterile closure of the packagebefore use, and to be resealable after use. The adhesive preferably hasa strength to withstand a pulling force in the range of 3-10 N. Theadhesive can e.g. be an acrylate emulsion, or an acrylate based hot meltadhesive.

The third sheet material further preferably comprises a weakened areaforming a seal integrity mark. Hereby, it is ensured that the seal hasnot been broken before use, ensuring full integrity of the product.Preferably, the seal integrity mark is arranged between the tab and thepart of the third sheet material overlying the perforation line. Theweakened area preferably comprises weakened or perforated lines arrangedin a pattern, e.g. as illustrated in the drawings, making part of thethird sheet material to remain adhered to the first sheet materialduring peel off of the third sheet material.

The catheter assembly may further comprise a fourth sheet material 8arranged on the first sheet material, i.e. on the side of the packagebeing opposed to the third sheet material and the resealable opening.The fourth sheet material is also connected by means of an adhesive tothe package, and forms a tab 81 not provided with adhesive, said tabproviding a grip portion for exposure of said adhesive to form a holdingarrangement for the package. By means of this fourth sheet material, thecatheter assembly may e.g. be attached to a sink, a wall or the like,which enables very efficient and easy handling of the product, even foruser with reduced dexterity.

In order to ensure that the fourth sheet materials are not removedcompletely during peeling, perforated lines (not shown) may be arrangedon one or preferably both of the sides. The perforated lines preferablyextend from the outer side of the fourth sheet material, about in thecenter of the sheet material, towards the interior of the sheet in adirection away from the pulling tab. The tear line preferably ends in ahook or the like towards the side of the sheet, but not extendingentirely to the side of the sheet.

Alternatively, the fourth sheet may comprise two separate sheets: Aninner sheet 8, which is connected to the first sheet by means of e.g.adhesive 81, and an outer sheet 9, which is connected to the innersheet. The connection between the inner and outer sheet may also beprovided by means of adhesive 91. The adhesive may be provided on eitherthe outer surface of the inner sheet or the inner surface of the outersheet, or preferably on both. A tab 93 is provided in the outer sheet toallow for simple separation of the inner and outer sheets. In an area 92opposite the tab 93, the connection between the inner and outer sheetsis made stronger, e.g. by using a stronger adhesive. Hereby, separationof the two sheets, which is initiated by pulling the tab 93, is stoppedat this area 92, and the exposed areas with adhesive on the inner and/orouter sheets may be used to attach the package to any suitable surfaceor object.

The third and fourth sheet materials may e.g. be of polypropene(polypropylene), polyester or polyethene (polyethylene).

In a preferred embodiment, the package is elongate, and preferably hasan essentially rectangular forward part, in the form of an elongatepocket, and an enlarged rearward part. The enlarged rearward part may berectangular or of other shapes, such as having rounded corners, etc. Theenlarged rearward part is preferably dimensioned to accommodate thecatheter connector and the wetting fluid container. The elongate pocketis preferably dimensioned to accommodate, and narrowly surround, theinsertable part of the catheter. Hereby, a very compact product isobtained.

In use, the wetting fluid container is opened, for activation of thehydrophilic surface of the catheter. After sufficient wetting, the tabof the fourth sheet may be peeled, so that the catheter assembly can beconnected to a sink or the like. The tab of the third sheet is peeledopen, and the catheter is removed and used. Thereafter, the catheter maybe re-inserted, and the package can then be closed, and stored for laterdisposal.

A method of manufacturing the above-discussed catheter assemblypreferably comprises the following steps of producing the package,performed in any order:

-   -   Providing a first and second sheet material;    -   Deep drawing the first sheet into the appropriate trough shape.    -   Providing a resealable opening, e.g. by the sub-steps of:        -   Providing the non-closed loop perforated line in the second            sheet material by cutting the material;        -   Providing third sheet materials;        -   Optionally, providing the perforated lines in the third            sheet material;        -   Adhering the third sheet material to the first sheet            material;    -   Connecting the first and second sheet material to each other        along the edges, e.g. by means of welding;    -   Optionally, providing a hanging means, e.g. in the form of an        adhesive, which may include the sub-steps:        -   Providing one or two sheet(s) of a fourth sheet material;        -   Optionally, providing the perforated lines in the fourth            sheet material; and        -   Adhering the fourth sheet material to the first sheet            material.

In addition, the catheters and the wetting fluid container is providedand arranged within the package before the package is finally closed,and sterilization of the product is provided by means of e.g. radiation.

The third and fourth sheet material may be provided on large sheets,arranged on a layer of adhesive, and with the perforation linespre-arranged before assembly.

Specific embodiments of the invention have now been described. However,several alternatives are possible, as would be apparent for someoneskilled in the art. For example, although the wetting fluid in thedescribed embodiments has been arranged separated from the catheter, ina wetting fluid container, it is also possible to arrange the wettingfluid in direct contact with the catheter, thereby always maintaining aready-to-use state. Further, if a wetting fluid container is used, it ispossible to arrange this container close to the connector end of thecatheter, close to the insertion end of the catheter, or at any otherlocation within the receptacle. Still further, resealable openings maybe provided in other forms than in the above-indicated preferredembodiment. Further, a package without the fourth sheet is feasible, andother sheets may also be used. Further, other shapes for the variousperforation lines are feasible. Such and other obvious modificationsmust be considered to be within the scope of the present invention, asit is defined by the appended claims. It should be noted that theabove-mentioned embodiments illustrate rather than limit the invention,and that those skilled in the art will be able to design manyalternative embodiments without departing from the scope of the appendedclaims. In the claims, any reference signs placed between parenthesesshall not be construed as limiting to the claim. The word “comprising”does not exclude the presence of other elements or steps than thoselisted in the claim. The word “a” or “an” preceding an element does notexclude the presence of a plurality of such elements. Further, a singleunit may perform the functions of several means recited in the claims.

The invention claimed is:
 1. A medical device assembly, comprising: aurinary catheter including an insertion end and a non-insertion end, thecatheter having a hydrophilic surface coating; a wetting fluid foractivation of said hydrophilic surface coating; and a packageaccommodating the catheter and the wetting fluid, wherein the packagecomprises: a first sheet of material, having been deep drawn into atrough shape, and a second sheet of material, the package furthercomprising an opening arranged within the bounds of the second sheet ofmaterial, wherein: the second sheet of material is joined around an edgewith an edge of the first sheet of material, the opening is arranged ina section of the package housing the non-insertion end of the catheter,and a third sheet of material is arranged over, and with a margincovering, said opening and connected to the second sheet of materialwith adhesive, thereby providing a resealable opening in the package;wherein the opening in the second sheet of material is formed as aperforation line extending along a non-closed loop, the perforation linedefining a flap opening, wherein the non-closed loop defining the flapopening debouches towards the end of the package housing the insertionend of the catheter.
 2. The medical device assembly of claim 1, whereinthe first and the second sheets of material are connected together bywelded joints.
 3. The medical device assembly of claim 1, wherein thetrough of the first sheet of material forms a narrow forward part of thepackage having first spaced wall portions for housing and narrowlysurrounding the insertion end of the catheter and a wider rearward partof the package having second spaced wall portions for housing thenon-insertable end of the catheter.
 4. The medical device assembly ofclaim 1, wherein the second sheet of material is essentially planar. 5.The medical device assembly of claim 1, wherein the non-closed loopincludes loop ends directed towards interior of the non-closed loop. 6.The medical device assembly of claim 1, wherein the adhesive is adaptedto maintain a sterile closure of the package before use, and to beresealable after use.
 7. The medical device assembly of claim 1, whereinthe third sheet forms a first tab not provided with adhesive, said firsttab providing a grip portion for peel opening.
 8. The medical deviceassembly of claim 1, wherein the third sheet covers the opening with amargin exceeding 2 mm.
 9. The medical device assembly of claim 1,wherein the wetting fluid is arranged separately from said catheter inthe package.
 10. The medical device assembly of claim 8, wherein thewetting fluid is arranged in a wetting fluid container within thepackage.
 11. The medical device assembly of claim 1, wherein the wettingfluid is arranged in direct contact with the hydrophilic surface of themedical device to always maintain a ready-to-use state.
 12. The medicaldevice assembly of claim 1, further comprising a fourth sheet ofmaterial arranged on the first sheet, the fourth sheet located on a sideof the package being opposed to the resealable opening.
 13. The medicaldevice assembly of claim 12, wherein the fourth sheet is connected tothe first sheet by an adhesive, the fourth sheet including a second tabnot provided with adhesive, the second tab providing a grip portion forexposure of the adhesive to form a holding arrangement for the package.14. The medical device assembly of claim 1, wherein the first and secondsheets comprise laminated sheets, having a weldable inner layer and aprotective outer layer.
 15. The medical device assembly of claim 1,wherein the first sheet further comprises a planar rim around aperimeter thereof.
 16. The medical device assembly of claim 15, whereinthe planar rim further comprises rounded corners.
 17. The medical deviceassembly of claim 7, wherein the first tab is arranged in an end of thethird sheet and is directed away from the end of the package housing theinsertion end of the catheter.
 18. The medical device assembly of claim1, wherein the trough further comprises at least two depths, a firstportion of the trough having a first depth and a second portion of thetrough having a second depth.
 19. The medical device assembly of claim18, wherein the second depth is greater than the first depth, andwherein the insertion end of the catheter is housed in the first portionof the trough and the non-insertable end of the catheter is housed inthe second portion of the trough.
 20. The medical device assembly ofclaim 1, further comprising an applicator releasably attached to thenon-insertable end of the catheter, arranged to be released prior to useto aid in manipulating the catheter during insertion without directlycontacting the surface of the catheter.
 21. The medical device assemblyof claim 20, wherein the applicator is in the form of a tube, sleeve orcuff.
 22. A medical device assembly, comprising: a urinary catheterincluding an insertion end and a non-insertion end, the catheter havinga hydrophilic surface coating; a wetting fluid for activation of saidhydrophilic surface coating; and a package accommodating the catheterand the wetting fluid, wherein the package comprises: a first sheet ofmaterial, which has been deep drawn into a trough shape, and a secondsheet of material, the package further comprising an opening arrangedwithin the bounds of the second sheet of material, wherein the secondsheet of material is joined around an edge with an edge of the firstsheet of material, wherein the opening is arranged in a section of thepackage housing the non-insertion end of the catheter, and wherein athird sheet of material is arranged over, and with a margin covering,said opening and connected to the second sheet of material withadhesive, thereby providing a resealable opening in the package, whereinthe third sheet forms a first tab not provided with adhesive, said firsttab providing a grip portion for peel opening, and wherein the first tabbeing arranged in an end of the third sheet is directed away from theend of the package housing the insertion end of the catheter when theresealable opening is closed and covered by the third sheet.